Site & scope
Current authorisations and certificates, dosage-form fit and manufacturing-site allocation.
QUALITY · GMP · TECHNICAL REVIEW
Quality documentation for your decision
Assess the site, dosage form and project against a controlled quality package.
A site-specific quality and authorisation manufacturing platform
Our two-site operating model connects development and manufacturing under the applicable quality framework. QA provides the current manufacturing authorisations, GMP certificates, national appendices and relevant scope documents for partner qualification.
Site 1 GMP certification
Site 1 now also has GMP certification. Request the current site-specific certificate, manufacturing authorisations and exact scope from QA before supplier qualification. Site allocation, technology transfer and any backup production remain subject to the applicable authorised scope, validation and available capacity.
A practical qualification package
Technical readiness
Specifications, analytical methods, transfer plan, stability strategy and agreed validation responsibilities.
Quality agreement
Change control, deviations, batch documentation, complaints, release responsibilities and communication routes.
Formulated Without
Our ingredient-screening policy supports selected formulation briefs. Exclusions are applied according to product category, compatibility and client requirements; they do not imply that every excluded ingredient is unsafe or that one policy applies to every medicine.
Explore the ingredient policySpeak with the Laboratories
A European base for your next complex programme.
EUROPEAN CMO / CDMO · NEARSHORING
Nearshoring for complex molecules and biotechnology startups: from formulation and technology-transfer assessment to an agreed non-sterile manufacturing programme in Athens.